The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The purpose of this study is to investigate whether patients with diabetes-related peripheral neuropathic pain also have non-recognized damage to the intestine caused by autonomic neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic and as well as visceral sensory nerves. Classical autonomic parameters from electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course when patients develop gastroparesis, however an earlier recognition of this nerve damage may help clarifying the fundamental pathomechanisms and thereby optimize treatment for this patient group in the future.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Sampling Method:

Probability Sample

Study Population

Patients with verified diabetic neuropathy.

Criteria

Inclusion Criteria:

Male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria (World Health Organization).

Proven peripheral neuropathy.

Oral and written consent, with documentation that all relevant information about the program is given to the patient.

The patient must be willing and able to, to meet the planned visit and meet the planned curriculum, including the participation in the experimental investigations.

Exclusion Criteria:

Pregnancy or breastfeeding

Medical or surgical disease for the study doctor's assessment makes the patient unsuitable for participation in the study

Previous or ongoing major depression

Patients who can or will not comply with the recommended instructions given by the study doctor

Use of analgesic opioid medication less than 24 hours before screening